REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT by CORGENIX, INC.

The REAADS Monoclonal Free Protein S Antigen Test Kit is an in vitro diagnostic assay for the quantitative determination of Free Protein S levels in human citrated plasma (as a percent of normal concentration) by enzyme-linked immunosorbant assay (ELISA). The REAADS Monoclonal Free Protein S Antigen Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Device Description

The REAADS Monoclonal Free Protein S Antigen Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. A capture monoclonal antibody specific for human Free Protein S is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available Free Protein S to bind to the anti-human Free Protein S monoclonal antibody on the microwell surface. The plates are washed to remove unbound proteins or other plasma molecules. Bound Free Protein S is quantitated using horseradish peroxidase (HRP) conjugated anti-human Protein S detection polyclonal antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2,O.) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450nm. Free Protein S relative percent concentrations in patient plasma are determined against a curve prepared from the reference plasma provided with the kit. Patient ODs are used to determine Free Protein S antigen levels in relative percent concentrations from a reference curve. The reference curve is produced by testing multiple dilutions of an assayed reference plasma supplied with the kit.

AI/ML Overview

This document describes the REAADS Monoclonal Free Protein S Antigen Test Kit, an in vitro diagnostic assay, and its comparison to a predicate device, the REAADS Protein S Antigen Test Kit (PEG Method).

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Equivalence to predicate device (REAADS Protein S Antigen Test Kit (PEG Method))	The coefficient of correlation (r) for all plasma samples (including suspected deficient samples) was 0.956.
Statistical similarity between the two methods	A P-value of 0.109 (by single factor ANOVA) was reported, indicating statistical similarity.
Comparable performance characteristics	Although differences were observed, the performance characteristics were deemed comparable. The improved specificity of the Monoclonal Test Kit was noted.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions "all plasma samples, including the suspected deficient samples" were used for the correlation study. However, the exact number of samples is not specified in the provided text.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It mentions "patient plasma" and "clinical samples," suggesting human samples were used in a clinical study context, but further details are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The comparison is made between the new device and a predicate device (the PEG Method), implying the predicate device's results serve as a reference, but there's no mention of expert-established ground truth for the test set.

4. Adjudication Method for the Test Set

This information is not provided in the document. The study compares the new device's results to the predicate device's results, but there's no mention of an adjudication process involving multiple readers or experts for this comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (ELISA test kit), not an imaging or diagnostic AI requiring human interpretation, so MRMC is not applicable in this context. The study compares two test kits.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The REAADS Monoclonal Free Protein S Antigen Test Kit is an ELISA-based assay that provides quantitative results. Its performance is evaluated intrinsically through its chemical reactions and detection, not through human interpretation of an algorithm's output. Therefore, the reported performance (correlation with the predicate device) represents the standalone performance of the test kit itself.

7. The Type of Ground Truth Used

The "ground truth" for the comparative study was the results obtained from the legally marketed predicate device, the REAADS Protein S Antigen Test Kit (PEG Method). This acts as the comparative standard to establish equivalence.

8. The Sample Size for the Training Set

This information is not applicable/provided. ELISA kits do not typically have a "training set" in the same way machine learning algorithms do. The kit is developed based on established biochemical principles and validated against known samples and existing methods. The "reference plasma provided with the kit" is used to create a reference curve for each run, but this is part of the assay's operational procedure, not a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the reasons stated above (not a machine learning algorithm). The "ground truth" in the context of the kit's operation would be the known concentrations of Protein S in the reference plasma (assayed reference plasma) provided with the kit, which is used to generate the standard curve. The establishment of this reference plasma's "ground truth" is not detailed here but would typically involve highly controlled and verified methods.

Summary

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SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS REAADS Monoclonal Free Protein S Antigen Test Kit

November 3, 1998

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The REAADS Monoclonal Free Protein S Antigen Test Kit is compared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is REAADS Protein S Antigen Test Kit (K972482/51) currently manufactured and marketed by Corgenix, Inc., Westminster, Colorado.

The intended use of the device is for the quantitative determination of Free Protein S Antigen in human citrated plasma (as a percent of normal concentration) by enzyme-linked immunosorbant assay (ELISA). Plasma levels of Free Protein S may be used in conjunction with results in other assays as an aid in diagnosing congenital or acquired Protein S deficiencies associated with thrombotic disease. A decreased Protein S activity in plasma may be the result of low concentrations or abnormal function of the Protein S molecule. Using an ELISA with a monoclonal antibody allows the direct measurement Free Protein S without PEG precipitation. Measurement of plasma levels of both Total and Free Protein S are useful to determine the type of defect in patients with Protein S deficiency.

Test results for clinical samples demonstrate that the REAADS Monoclonal Free Protein S Antigen Test Kit and REAADS Protein S Antigen Test Kit (PEG Method) are equivalent. The coefficient of correlation (r) for all plasma samples, including the suspected deficient samples was 0.956, with a P-value of 0.109 (by single factor ANOVA), indicating the results by the two methods are statistically similar. Although differences between the assays are observed, the performance characteristics are comparable, The differences may be attributed to the improved specificity of the REAADS Monoclonal Test Kit compared to the REAADS PEG Test Kit. The clinical studies performed demonstrate that the REAADS Monoclonal Free Protein S Antigen Test Kit is safe and effective.

Nana Destin

Nanci Dexter
Director, Quality Assurance and Regulatory Affairs

Date

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In response to the requirements by the SMDA of 1990, enclosed on a separate letterhead page is the Summary of 510(k) Safety and Effectiveness information upon which the substantial equivalence determination is based.

Please contact me at the address, phone, or fax number shown if you have questions or comments about this submission.

Sincerely,

Nanci Deyton

Nanci Dexter Director, Quality Assurance and Regulatory Affairs

PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT [As required by 21 CFR 807.87(j)]

I certify that, in my capacity as Director of Quality Assurance and Regulatory Affairs for Corgenix, Inc., I believe to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.

Nânie Deyter

Nanci Dexter

11-3-98

Date

12061 TEJON STREET · WESTMINSTER, CO · 80234 U.S.A. PHONE: 303.457.4345 FAX: 303.457.4519 www.corgenix.com

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 22 1998

Ms. Nanci Dexter Director of Quality and Regulatory Affairs CORGENIX, INC. 12061 Tejon St. Westminster, CO 80234

Re: K983914 Trade Name: REAADS Monoclonal Free Protein S Antigen Test Kit Regulatory Class: II Product Code: GGP Dated: November 3, 1998 Received: November 4, 1998

Dear Ms. Dexter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls The general controls provisions of the provisions of the Act. Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K983914

Device Name: REAADS Monoclonal Free Protein S Antigen Test Kit

Indications for Use:

The REAADS Monoclonal Free Protein S Antigen Test Kit is intended to be used by clinical (hospital and reference) laboratories.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Tito E. Vasim

Prescription -

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).